Consensus-based standards development processes--serving the needs of the environment and public-health community. (Guest Commentary).

Make no mistake about it-- standards are important! Standards play an important role in protecting public safety, setting benchmarks, and establishing consistency in product evaluation. Standards also are a means of communicating procedures and criteria applied to a product or system, and they provide a mechanism for establishing consensus among the community of interested parties. Regulators and jurisdictional authorities, for example, rely on standards that support statutes and regulations to achieve community environmental health goals and to establish desired safety requirements.

While many state and local agencies have expertise adequate to develop a proposed text, hold public hearings, and adopt appropriate criteria for many routine regulations, the expertise and resources available for developing complex and deeply involved scientific and health effect regulations are limited. The process can be long, expensive and politically sensitive. There also is a need for requirements and processes to be relatively uniform among communities (or states) to avoid confusion and damaging debate concerning health and safety threats.

This is an area in which voluntary standards developed by accredited organizations have the potential to provide help. The process of developing such standards involves all interested stakeholders in the establishment of scientifically correct and acceptable standards. Standards developed under procedures recognized by the American National Standards Institute (ANSI) become American National Standards and can be referenced without cost by any regulatory agency in local or state regulations. The savings in time and tax dollars, along with the credibility gained through input of scientific, regulatory, consumer, and industry resources, represent a significant value for the regulatory agency The benefits to the industry are more uniform regulations, and the benefits to the community are state-of-the-art compliance requirements.

The business community, the public, standards development and certification organizations, and enforcement agencies are realizing the importance of standards in their areas of interest and are calling for an increased voice in the standards development process. Recognizing the importance of standards, they expect an open process in which all points of view are heard, in which all stakeholders can fully participate, and in which the principles of consensus and due process are followed. Anything less compromises the delicate balance of competing interests and casts doubts on the validity of the process and the resulting standard.

Standards Development

Many methods and processes can be used to develop standards. Standards may be developed by standards organizations such as the American Society for Testing and Materials (ASTM) or the National Fire Protection Association (NFPA), or by trade associations such as the Water Quality Association (WQA). Then there are professional societies such as the American Water Works Association (AWWA) and the American Society of Sanitary Engineers (ASSE), as well as individual companies creating standards for their own internal use, accredited committees, industry consortia, and certification bodies such as Underwriters Laboratories, Inc. (UL) and NSF International.

The rules applied to standards development can be different for each of these various entities depending on the circumstances and the application of the standard. If a company needs to prepare a document to govern the way something is carried out in its own organization, it may establish a standard, within legal and ethical boundaries, and has no obligation to explain that standard to anyone else (unless the standard is subject to external accreditation). If the standard is intended to be used among just a few interests, such as two or three companies doing business with each other, then there is similar freedom to develop and administer the standard as the participants choose.

If, however, the standard is intended to be useful to a broad and public audience, then uniform procedures are needed to ensure fairness. In the United States, ANSI serves as the official body to oversee voluntary consensus national-standards development. In that capacity, ANSI develops policies and procedures for standards developers to ensure that the principles of openness, due process, and consensus are defined and followed. Developers who wish to have their standards recognized as American National Standards must apply for accreditation with ANSI. Accredited developers are authorized to apply the ANSI logo to their standards to demonstrate that the standards were developed in accordance with the principles of openness, due process, and consensus, ANSI also provides oversight by having an independent board review the standards development documentation for a contested standard before the standard can be designated as ANSI approved and by conducting periodic audits of developers to make sure they are foll owing their accredited procedures.

Principles of an Open Voluntary Consensus National-Standards Process

The following list briefly describes the basic principles of a voluntary consensus national-standards development process:

* Openness--all affected and materially interested parties have the opportunity to attend and participate directly in all stands development meetings of the consensus body. The balanced consensus body votes on approval of the standard. ANSI defines openness as follows: "Participation shall be open to all persons who are directly and materially affected by the activity in question. There shall be no undue financial barriers to participation. Participation shall not be conditional upon membership in any organization, nor unreasonably restricted on the basis of technical qualifications or other such requirements."

* Due process--allowing for equity and fair play, due process ensures that all expressed views are considered. As part of the process, all objectors are notified in writing of the disposition of their comments and the reasons for that disposition, and all comments are circulated to the consensus body to provide the opportunity for the members to reconsider their vote on the basis of the objections. Objectors also have the right to appeal their concerns to the developer of the standard.

A balance of interests on the consensus body is another important element of due process. While an exact numerical balance of interests is not a requirement, it is important that no single interest be able to dominate the process. A relatively even balance is optimal.

* Consensus--demonstrated by the vote of the consensus body, a consensus signifies that substantial agreement has been reached. This means approval by more than a majority, but not necessarily unanimity Many standards developers require a minimum two-thirds approval vote for consensus to be achieved.

The Accredited Organization Method of Standards Development

Environmental and public-health standards development organizations like UL use the Accredited Organization Method. This method is an ANSI process that engages the three main categories of stakeholders (regulators, users, and manufacturers) in essentially equal balance to participate in development of a standard that will serve their individual and collective needs. The goal is to include organizational representation of all affected and interested parties in order to develop the best possible scientific standard, one that meets the safety needs and wins the acceptance of all participants.

The Accredited Organization Method of standards development process incorporates the following principles:

* Early participation--all interested parties have the opportunity to meet and provide input from the very beginning of the process.

* Open meetings--consensus body meetings are freely open to all interested parties without restriction. Consensus bodies include voting members as well as nonvoting members such as consumers, competing certification organizations, advocacy groups, legal counsel, and the media.

* Open membership--as described above, the consensus body provides the basis for open and balanced participation among all directly and materially affected parties. Accredited Organization Method standards developers should actively recruit and welcome representatives from each interest category (e.g., regulatory authorities, consumers, government, manufacturers, trade associations, testing and certification labs) to serve as voting members. The balance and the size of the group are important, but a standards developer must not use these considerations to exclude affected parties from membership or attendance at meetings.

* Continuous maintenance--standards developers find it convenient to proceed with concurrent development of requirements and ANSI recognition under a "continuous-maintenance" method. The continuous-maintenance method allows revisions of ANSI-recognized standards through an accredited consensus process as the revisions are developed, as opposed to every five years under the once popular "periodic-maintenance" method. The new approach means that an ANSI standard can be constantly updated to reflect new technologies and field experience. It also ensures that there is seldom a gap between the standard used for product evaluations and the ANSI-approved version of that standard, which is adopted into local codes and ordinances. Continuous maintenance also means that the standard is open for comment or proposals at any time. All such requests are logged and acted upon.

* Final steps--after the vote of the consensus body, a variety of final steps can conclude the standards development process. Some standards developers use internal final review and approval while others might use other methods. For example, UL relies on a vote by its Environment and Public Health (EPH) Council. The council is a blue-ribbon panel of international, national, state, and local environmental and public-health regulators, university experts, and consulting experts. Once the EPH Council approves a standard, the standard is designated as an ANSI/UL standard.

* Audited designator--organizations with a history of successful standards development can obtain ANSI "audited designator" status. After going through a rigorous audit by ANSI, a standards developer may be granted the authority to self-designate developed standards that have completed the accredited standards processes. A standard thus can receive ANSI designation without first having been submitted to the independent ANSI Board of Standards Review for approval.

Conclusion

The environmental and public-health community is well served by the voluntary consensus standards process and the resulting nationally recognized standards, It is to everyone's advantage that the process is truly open to all interested parties so that the best possible national voluntary standard is obtained, with input from all sources that have experience or expertise contributing to development and maintenance. The standards should be technically sound and nationally respected, with no inclusion or exclusion of requirements that may lessen their value or objectivity NEHA members who participate in the voluntary consensus standards process recognize and appreciate the opportunity to be heard. The process contributes to quality uniform, national voluntary standards that can be referenced in local and state regulations and to laws that make for a safer world.

Corresponding Author: George Kupfer, c/o Joseph E Hirschmugl, Global Communication Services, Underwriters Laboratories, Inc., 333 Pfingsten Road, Northbrook, IL 60062-2096.